Combination Therapy for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMichael McNamara, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Case Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil followed by surgery and response based concurrent chemotherapy and radiation therapy works in treating patients with cancer of the esophagus, gastroesophageal junction, or gastric cardia. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving chemotherapy followed by surgery and response based chemotherapy and radiation therapy may kill more tumor cells.

Eligibility Criteria

This trial is for adults with specific cancers of the esophagus, gastroesophageal junction, or gastric cardia. They must be in good physical condition (ECOG 0-1), have adequate blood counts and organ function, and no severe neuropathy. Pregnant women, those with distant metastasis or another active cancer (with some exceptions), prior treatments for this cancer, certain infections like hepatitis B/C or HIV, serious heart conditions, or other medical issues that could affect participation are excluded.

Inclusion Criteria

Alkaline phosphatase ≤ 3X the institutional ULN

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3X the institutional ULN

My cancer is a type of adenocarcinoma located in my esophagus, GEJ, or stomach.

+10 more

Exclusion Criteria

My cancer diagnosis is specifically adenocarcinoma.

Patients who are pregnant or lactating will not be eligible; pregnant patients are ineligible

Patients with known infection with human immunodeficiency virus (HIV) will not be eligible

+12 more

Participant Groups

The study tests a combination of chemotherapy drugs (oxaliplatin, leucovorin calcium, fluorouracil) followed by surgery and then more chemo alongside radiation therapy based on how well the patient responds to initial treatment. The goal is to see if this approach is effective at stopping tumor growth by killing cells or preventing them from dividing.

2Treatment groups

Experimental Treatment

Active Control

Group I: Negative Pathologic ResponseExperimental Treatment7 Interventions

Patients with \>50% viable tumor cells remaining in the surgical specimen, will receive postoperative chemo-radiotherapy with weekly carboplatin and paclitaxel.

Group II: Positive Pathologic ResponseActive Control5 Interventions

Patients with ≤50% viable tumor cells remaining in the surgical specimen will receive postoperative chemo-radiotherapy with the mFOLFOX6 regimen

Fluorouracil is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as 5-Fluorouracil for: